Effectiveness of Mindfulness-based Stress Reduction for Improving Quality of Life in Patients With Cardiovascular Disease: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Health Related Quality of Life
研究概览
简要总结
Patients with atherosclerotic cardiovascular disease (i.e. peripheral artery disease, ischemic heart failure, myocardial infarction) are randomised to (1) treatment as usual (i.e. best medical care) or (2) treatment as usual (i.e. best medical care) in combination with an eight-week mindfulness-based stress reduction programme.
详细描述
Rationale: Distress, including depression, anxiety, and chronic stress, is common among patients with cardiovascular disease. This reduces their quality of life and worsens their prognosis. A structured mindfulness training programme, such as the 8-week mindfulness-based stress reduction (MBSR) course, may reduce distress, improve quality of life, support a healthy lifestyle and modify cardiovascular risks. The aim of this randomised controlled trial is to determine whether MBSR improves the quality of life in patients with atherosclerotic cardiovascular disease.
Objective: The primary objective is the effect of MBSR on quality of life. Secondary objectives are the effects of MBSR on mental health, mindfulness, and cardiovascular risk factors, and the cost-effectiveness of MBSR.
Study design: Multicenter Torgerson preference randomised controlled trial. Complemented with qualitative research in a maximum of 12 patients in the intervention arm.
Study population: Patients with atherosclerotic cardiovascular disease (i.e. coronary artery disease, ischemic heart failure, and peripheral artery disease).
Intervention: The intervention group will receive an 8-week MBSR programme in addition to treatment as usual (TAU+MBSR), while the control group will receive only treatment as usual (TAU).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (i.e. older than 18 years)
- •Established ASCVD (i.e. coronary artery disease, ischemic heart failure, or peripheral artery disease)
排除标准
- •Current acute cardiovascular event (myocardial infarction, major stroke, acute limb ischemia in prior 2 weeks)
- •Critical limb ischemia
- •Terminal illness
- •History of psychosis
- •Current severe psychiatric disorder
- •Current psychotherapy
- •Non-Dutch speaking
- •Cognitive impairment
- •Behavioural problems that distort group therapy
- •Active mindfulness/meditation or yoga practice within the past year
- •Current participation in another clinical trial that interferes with this study's intervention or primary outcome
结局指标
主要结局
Health Related Quality of Life
时间窗: Baseline, 3, 6, 12, 24, and 60 months.
Health related quality of life (HRQOL) will be measured with the SF-36 (Short Form) questionnaire, which contains 36 questions. The total score is based on a 100-point scale, with a higher score indicating a higher quality of life. Physical health summary scores are derived using four scales (physical functioning, role functioning due to physical problems, bodily pain and general health perceptions), while mental health summary scores are derived using four other scales (mental health, role limitations due to emotional problems, social functioning and vitality). The change of scores over time for all time points will be reported.
次要结局
- Depression(Baseline, 3, 6, 12, 24, and 60 months.)
- Anxiety(Baseline, 3, 6, 12, 24, and 60 months.)
- Perception of stress(Baseline, 3, 6, 12, 24, and 60 months.)
- Hair cortisol levels(Baseline, 3, 6 and 12 months.)
- Smoking status(Baseline, 3, and 12 months.)
- Blood pressure(Baseline, 3, and 12 months.)
- Glycated hemoglobin (HbA1c)(Baseline, 3, and 12 months.)
- Five facets of mindfulness(Baseline, 3, 6, 12, 24, and 60 months.)
- Alcohol use(Baseline, 3, and 12 months.)
- Body Mass Index (BMI)(Baseline, 3, and 12 months.)
- Serum lipids(Baseline, 3, and 12 months.)
- Cost-effectiveness(12 months)
- Heart rate(Baseline, 3, and 12 months.)
研究者
Joep Teijink
Principal Investigator
Catharina Ziekenhuis Eindhoven